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Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water

Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water - Elucidation of Energy Metabolism Mechanisms in Parkinson Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058221
Enrollment
10
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

On the first day of the study, participants will ingest doubly labeled water containing stable isotopes of oxygen and hydrogen. The volume administered will be approximately 1.5 g per kilogram of body

Sponsors

International University of Health and Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible participants will be male or female patients diagnosed with Parkinson disease HY up to IV, aged 20 years or older and under 80 years, who have provided written informed consent to participate in this study. Prior to obtaining consent, participants will be provided with a detailed explanation of the study using an information sheet, including a description of the procedures, devices, and facilities involved, to ensure full understanding. Inclusion criteria: Patients diagnosed with Parkinson disease who visit the Department of Neurology at Takagi Hospital or Fukuoka Sanno Hospital between April 1, 2025, and March 31, 2026. Patients capable of providing written informed consent of their own free will. Patients aged 20 years or older and under 80 years at the time of consent. Disease severity classified as H&Y stage up to IV. No restriction based on sex. No restriction based on inpatient or outpatient status.

Exclusion criteria

Exclusion criteria: Participants will be excluded from the study if they meet any of the following conditions Individuals unable to comply with the study protocol, including proper sample storage and scheduled outpatient visits. Individuals with comorbid gastrointestinal disorders that cause malabsorption. Individuals with comorbid endocrine disorders that affect energy intake. Individuals with comorbid psychiatric disorders that result in pathological appetite loss. Individuals with comorbid neoplastic diseases. Individuals with severe renal impairment. Individuals with cognitive impairment. Individuals in a state of starvation. Individuals with a BMI of 30 or higher. Individuals using implanted medical devices such as deep brain stimulators. Individuals with extremely irregular dietary habits. Individuals currently participating in, or intending to participate in, other clinical trials involving the consumption of food or medications, or the application of cosmetics or pharmaceuticals. Individuals with habitual alcohol consumption or smoking that cannot be controlled during the study period. Any individual who, despite obtaining the attending physicians consent, is deemed by the principal investigator to be unsuitable for safe participation in this study.

Design outcomes

Primary

MeasureTime frame
Total daily energy expenditure measured by the elimination rates of 18O and 2H.

Countries

Japan

Contacts

Public ContactShinsuke Fujioka

Inernational University of Health and Welfare Department of Neurology

s.fujioka@ihwg.jp0944-87-0001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026